Implantable pulse generators, such as pacemakers, defibrillators or implantable cardioverter defibrillators (“ICD”) provide electrotherapy to cardiac tissue via implantable cardiac electrotherapy leads. Delivery devices, such as delivery catheters or sheaths, are used to place leads in specific cardiac anatomies during implantation of the pulse generator. The delivery devices also navigate the venous system and cardiac anatomy to locate specific anatomical locations and serve as a conduit through which leads and other cardiac surgical devices are delivered. Upon placement of the lead, the delivery catheter is removed and care is taken to not disrupt the position of the implanted lead. Non-disruptive removal is also advantageous when the delivery devices are used to deliver other cardiac surgical devices, such as inner catheters, outer sheaths, guidewires and other accessories.
A common technique for accomplishing the non-disruptive removal of the delivery device involves slitting or otherwise cutting the catheter over the lead or other cardiac surgical device using a small blade known as a slitter. A typical catheter used in this technique is designed such that the force required to slit the sheath is as low and as consistent as possible. However, the hub of the delivery catheter typically requires considerably more force to slit through than is required for the shaft. That is, when slitting the catheter, the user begins by generating enough force to slit through the hub. As the slitter transitions from the hub to shaft, this force is excessively high and results in an acceleration or jerk. In the context of an implantable cardiac lead, if this jerk is severe, it may tear the cardiac tissue or disrupt lead placement, which results in a major procedural delay. Similarly, disruption of other cardiac surgical tools, such as an inner catheter, may cause damage to cardiac tissue or major procedural delays.
In order to prevent vascular bleedback, delivery devices may have a hemostasis valve coupled thereto to provide hemostasis sealing around the cardiac surgical devices. Leads or other devices to be passed through the hemostasis valve are often soft and flimsy. As a result, a valve bypass tool may be required to facilitate the passage of leads or other devices through the hemostasis valve. Employing valve bypass tools known in the art can increase the time associated with a medical procedure such as the implantation of a lead. Also, the removal of valve bypass tools known in the art from about an implanted lead can disrupt lead placement.
There is a need in the art for a slittable delivery device assembly for a cardiac surgical device that will reduce or eliminate the hub-to-shaft transitional jerk and reduce the potential for lead or cardiac surgical device displacement or dislodgement during removal of a delivery device assembly. There is also a need in the art for a valve bypass tool that reduces the time and complexity associated with the passage of a lead or cardiac surgical device through a hemostasis valve and reduces the potential for lead or cardiac surgical device displacement or dislodgement during the removal of the valve bypass tool. There is also a need in the art for methods of manufacturing the slittable delivery assembly, the valve bypass tool, and kits including the delivery device assembly and/or valve bypass tool.